BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 18481186 · Received January 9, 2024

    Report

    Report Number
    1038671-2024-00061
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    May 15, 2015
    Report Date
    July 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 314-13-14 - EQUINOXE CAGE GLENOID LARGE, BETA (B)(6). 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT (B)(6). 300-50-15 - 1.5MM SHORT REP PLATE (B)(6). 304-22-09 - 8.5MM PLATFORM FX STEM RIGHT (B)(6).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REPORTED REVISION DUE TO SUBLUXATION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, ROTATOR CUFF FAILURE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. SUBLUXATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    STUDY: (B)(6). SUBJECT: (B)(6). AS REPORTED BY THE (B)(6), THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2015 AND PRESENTED ON AND UNKNOWN DATE WITH ANTERIOR SUBLUXATION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THE OUTCOME OF THIS EVENT IS RESOLVED BY REVISION ON (B)(6) 2015. HEIGHT: 61 IN. BMI: 27. DIAGNOSIS: OSTEOARTHRITIS. ADD'L INFO: FORMER 25 YR SMOKER QUIT IN 2012. 310-00-47 - XS HUMERAL HEAD, 47MM XS OFFSET HUMERAL HEAD: (B)(6). 510K: K140063. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598509 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female